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RecruitingLast updated: 4 February 2025

This is study will evaluate a drug called BGB-53038 when used by itself for people with advanced or metastatic solid cancers with KRAS mutations or amplification, as well as when used in combination with other treatments for people with non-small cell lung cancer or colorectal cancerA Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, As Monotherapy or in Combinations in Patients with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications

Clinical summary

Summary

This study consists of two phases: Phase 1A Dose Escalation and Safety Expanion, and Phase IB Dose Expansion.

Phase 1a Part A (Monotherapy Dose Escalation): sequential cohorts will be evaluated to determine the recommended dose for expansion (RDFE) of oral BGB-53038 as monotherapy.

Phase 1a Part B (Monotherapy Safety Expansion): participants will be enrolled at dose levels determined in Part A with the Safety Monitory Committee to confirm the final RDFE(s) for oral BGB-53038 monotherapy.

Phase 1a Part C (Combination Therapy Dose Escalation): Sequential cohorts with increasing doses will be eva,uated to determine the RDFE(s) for BGB-53038 in combination with intravenous infusino (IV) of tislelizumab for people with non-small cell lung cancer or cetuximab IV for people with colorectal cancer.

Phase 1b Part D (Monotherapy Dose Expansion): Participants will be enrolled to receive teh RDFE(s) of oral BGB-53038 monotherapy.

Phase 1b Part E (Combination Therapy Dose Expansion): Participants will be enrolled to receive BGB-53038 at the RDFE(s) as determined in Part C of Phase 1a in combination with tislelizumab IV for people with non-small cell lung cancer or cetuximab IV for people with colorectal cancer.

Conditions

This trial is treating patients with advanced solid cancers, non-small cell lung cancer or colorectal cancer with KRAS mutation or wild-type amplification

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

BeiGene

Scientific Title

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, As Monotherapy or in Combinations in Patients with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications

Eligibility

Inclusion

  1. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Participants must have evidence of a KRAS mutation or wild-type amplification (copy number ≥ 8) based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by local laboratory
  4. Able to provide an archived tumor tissue sample or fresh biopsy sample.
  5. ≥ 1 measurable lesion per RECIST v1.1.
  6. Adequate organ function.
  7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, for > 7 days after the last dose of BGB-53038, > 120 days after the last dose of tislelizumab, or > 2 months after the last dose of cetuximab, whichever is later
  8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

Exclusion

  1. Participants with tumors harboring KRAS G12R mutation.
  2. Participants who have prior therapy with other anti-RAS treatment, including, but not limited to, therapy targeting specific KRAS allele mutation inhibitors, pan-KRAS inhibitors, and other pan-RAS inhibitors
  3. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable CNS metastases are eligible, provided they meet select criteria.
  4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  5. Participants with untreated chronic hepatitis B or chronic HBV carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening. Participants with active hepatitis C.
  6. Participants with clinically significant infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

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